The F.D.A.’s full approval of Pfizer’s Covid-19 vaccine is already making a difference. Within hours of the announcement yesterday, the Pentagon and several large companies and universities announced new vaccine mandates. President Biden, speaking at the White House yesterday afternoon, urged other organizations to follow: “Require your employees to get vaccinated or face strict requirements,” he said.
But the much-celebrated impact of the F.D.A.’s decision has a flip side: The monthslong wait to reach this point has had large costs.
It has delayed the hundreds of thousands of vaccinations that will now occur within the military and elsewhere. The lack of full approval has meant that some Americans who are skeptical of vaccination — but not firmly opposed to it — still have not gotten a shot, fueling the spread of the Delta variant and causing many unnecessary deaths. (These maps show that vaccination rates for people over age 65 are much lower in the U.S. than in Britain.)
Over the past week, about 1,000 Americans per day have died of Covid; vaccination would probably have saved more than 95 percent of them.
Why, then, has the F.D.A. been so slow to act?
The short answer is bureaucratic caution. The F.D.A.’s leaders wanted to hew as closely as possible to their normal process for granting full approval to a vaccine. They bestowed “emergency authorization” on the Covid vaccines from Pfizer, Moderna and Johnson & Johnson months ago, so that Americans could begin receiving shots. In the meantime, the F.D.A. spent months reviewing trial results before granting full approval to any Covid vaccine.
F.D.A. officials have defended this approach by pointing out — fairly — that a careful approval process can increase people’s confidence in a vaccine. But officials have also claimed that they had little choice but to follow the cautious path that they did. And that part of their defense is inconsistent with the facts.
‘Met our standards’
There are two basic ways to see that the F.D.A. did have a choice and could have acted more quickly than it did. The first is that the agency has acknowledged that it moved more quickly in this case than it normally does. A typical vaccine approval process takes between eight and 12 months; Pfizer’s Covid vaccine received full approval three and a half months after the company filed its application.
There is nothing magical about three and a half months, however. Once the F.D.A. had already departed from its usual process, it could have done so more aggressively than it did. Multiple medical experts have been urging so for months. No White House official, member of Congress or federal judge was threatening to stand in the way of an expedited process.
After all, the F.D.A. leaders made clear that they had made up their minds long ago about the substantive part of the decision to grant full approval. They publicly endorsed the vaccines, urging Americans to get shots. Dr. Janet Woodcock, the acting commissioner, said three months ago that the vaccines “have met our high standards for quality, safety and effectiveness.” Early last month, Dr. Peter Marks, who oversees the approval process, wrote, “If we truly want our lives to return to normal, the fastest way to do so is simple — get vaccinated right now.”
The wait for full approval, then, was more about process than science.
The F.D.R. approach
The second key point is that American history is rich with examples of government officials doing what the F.D.A. decided not to do in this case: overhaul their process in a time of crisis.
Franklin D. Roosevelt repeatedly broke with tradition — and endured confrontation with the courts — to fight the Great Depression. His administration, working closely with business, also threw out the normal bureaucratic procedures to build World War II ships, planes, tanks, bombs and other matériel with stunning speed. In this century, the Federal Reserve under Ben Bernanke took creative risks that helped keep the financial crisis of 2007-9 from becoming another Great Depression. (The title of Bernanke’s memoir is telling: “The Courage to Act.”)
In each of the instances, officials avoided taking steps that clearly violated the law. Yet they recognized that the law often includes gray areas and gives government agencies leeway to choose one of several approaches. During normal times, taking the cautious route and following procedural precedent tends to make sense. It minimizes chaos and mistakes.
But a national emergency can change the equation. In an emergency — like a depression, a war or a pandemic — government leaders will sometimes decide that the abstract benefits of bureaucratic continuity are smaller than the concrete benefits of preventing a depression, winning a war or saving lives. These leaders refuse to be bound by precedent.
In 1932, Roosevelt described his approach as: “Above all, try something.” In 2021, the F.D.A. took a different approach.
More virus news:
New York City will require all teachers, principals and school custodians to receive their first vaccine dose by Sept. 27.
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ARTS AND IDEAS
Two crises, 20 years apart
Spike Lee’s new documentary series on HBO — “New York Epicenters: 9/11-2021½” — is a mournful and irreverent tribute to his city. It chronicles the Sept. 11 attacks and the pandemic through interviews with dozens of New Yorkers. “With 20 years coming up since 9/11, and with people often saying of New York during Covid, ‘This is the epicenter,’ it was natural,” Lee said of the subject matter.
Some of the faces are familiar — Senator Chuck Schumer, Mayor Bill de Blasio, Rosie Perez — but most of the story is told through health care workers, firefighters, activists and survivors. His team interviewed over 200 people for the series. “We just wanted to be as well-rounded as possible, a kaleidoscope of witnesses,” he said.
In a Q. and A. with The Times, Lee also defended his decision to include Sept. 11 conspiracy theorists in the film: Viewers, he said, would “make up their own mind. My approach is put the information in the movie and let people decide for themselves.”
PLAY, WATCH, EAT
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Make cheese the main course with this vegetarian halloumi dish.
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Now Time to Play
The pangram from yesterday’s Spelling Bee was midtown. Here is today’s puzzle — or you can play online.
Here’s today’s Mini Crossword, and a clue: Same old, same old (five letters).
If you’re in the mood to play more, find all our games here.
Thanks for spending part of your morning with The Times. See you tomorrow. — David
P.S. The NATO alliance formally began 72 years ago today.
Here’s today’s print front page.
“The Daily” is about Mexico’s suit against U.S. gun manufacturers. On “The Ezra Klein Show,” Dr. Bessel van der Kolk discusses trauma.
Lalena Fisher, Natasha Frost, Ian Prasad Philbrick, Tom Wright-Piersanti, Ashley Wu and Sanam Yar contributed to The Morning. You can reach the team at [email protected].
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